Senior Engineer Validation

What you will do:

• Support new product and process introductions in accordance with Product Development Process (PDP) Design Controls and Quality System requirements.
• Collaborate with R&D Manufacturing Engineering Quality Regulatory and Operations teams to industrialize and transfer new products into manufacturing.
• Participate in manufacturing readiness activities including pilot builds process characterization verification and production ramp up . Should have strong understanding of the difference between verification and validation.
• Develop execute and maintain validation documentation including Validation Plans Risk Assessments Protocols Traceability Matrices and Final Reports.
• Lead and execute Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) activities for manufacturing equipment processes tooling fixtures and production systems.
• Support Master Validation Planning and validation lifecycle management activities.
• Ensure validation activities comply with GMP FDA ISO 13485 and internal quality requirements.

What you will need:

Required Qualifications:

• Bachelors degree in Mechanical Engineering Electrical Engineering Electronics Engineering Industrial Engineering Manufacturing Engineering or a related technical discipline.
• Minimum 6 years of experience in Validation Engineering Manufacturing Engineering Quality Engineering or a related discipline within medical devices pharmaceuticals biotechnology or other regulated industries.
• Hands-on experience executing IQ/OQ/PQ protocols for equipment processes tooling fixtures and manufacturing systems.
• Experience with reviewing test requirements derived from product requirements Validation and End-of-Line (EOL) Tester qualification and validation.
• Working knowledge of Computer System Validation (CSV) methodologies and regulatory expectations.
• Strong understanding of GMP FDA Quality System Regulation (21 CFR Part 820) ISO 13485 ISO 60601 and risk management principles.

• Experience with PFMEA Control Plans PPAP and process qualification methodologies.
• Working knowledge of MSA Gage R&R process capability analysis and statistical tools such as Minitab.
• Experience supporting New Product Development (NPD) design transfer and manufacturing scale-up activities.
• Strong problem-solving project management and technical documentation skills.
• Excellent communication skills and ability to collaborate effectively across multidisciplinary global teams.